U.S. patent application number 10/418929 was filed with the patent office on 2003-10-02 for bronchial obstruction device deployment system and method.
This patent application is currently assigned to Spiration, Inc.. Invention is credited to DeVore, Lauri J., Rimbaugh, Jenni.
Application Number | 20030183235 10/418929 |
Document ID | / |
Family ID | 21980467 |
Filed Date | 2003-10-02 |
United States Patent
Application |
20030183235 |
Kind Code |
A1 |
Rimbaugh, Jenni ; et
al. |
October 2, 2003 |
Bronchial obstruction device deployment system and method
Abstract
A system and method deploys a bronchial obstruction device in an
air passageway communicating with a lung portion to be at least
temporarily collapsed. The system includes a conduit configured to
be passed down a trachea, into a bronchus communicating with the
trachea and into the air passageway communicating with the lung
portion. The system further includes a capsule dimensioned to house
the bronchial obstruction device and to be advanced down an
internal lumen of the conduit into the air passageway. The capsule
has a break-away distal end configured to release the bronchial
obstruction device for deployment in the air passageway upon being
pushed from the capsule by a pusher member.
Inventors: |
Rimbaugh, Jenni; (Bothell,
WA) ; DeVore, Lauri J.; (Seattle, WA) |
Correspondence
Address: |
Frederick A. Kaseburg
GRAYBEAL JACKSON HALEY LLP
Suite 350
155 - 108th Avenue NE
Bellevue
WA
98004-5901
US
|
Assignee: |
Spiration, Inc.
|
Family ID: |
21980467 |
Appl. No.: |
10/418929 |
Filed: |
April 17, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10418929 |
Apr 17, 2003 |
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10052875 |
Oct 25, 2001 |
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6592594 |
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Current U.S.
Class: |
128/207.15 |
Current CPC
Class: |
A61B 17/12022 20130101;
A61B 2090/037 20160201; A61B 2017/1205 20130101; A61B 2017/242
20130101; A61B 17/24 20130101; A61F 2002/043 20130101; A61B
17/12104 20130101; A61M 2029/025 20130101; A61M 29/02 20130101;
A61B 17/12172 20130101 |
Class at
Publication: |
128/207.15 |
International
Class: |
A61M 016/00 |
Claims
What is claimed is:
1. A system for deploying a bronchial obstruction device in an air
passageway communicating with a lung portion to be at least
temporarily collapsed by the bronchial obstruction device, the
system comprising: a conduit configured to be passed down a
trachea, into a bronchus communicating with the trachea and into
the air passageway communicating with the lung portion, the conduit
having an internal lumen; and a capsule dimensioned to house the
bronchial obstruction device and to be advanced down the internal
lumen into the air passageway, the capsule being configured to
release the bronchial obstruction device for deployment in the air
passageway.
2. The system of claim 1 wherein the capsule sealingly houses the
bronchial obstruction device.
3. The system of claim 1 wherein the capsule includes a break-away
end portion to release the bronchial obstruction device.
4. The system of claim 1 further including a pusher that pushes the
bronchial obstruction device from the capsule.
5. The system of claim 1 further including an elongated extension
communicating with the capsule and dimensioned for receiving the
pusher.
6. The system of claim 5 further including a break-away wall
between the capsule and the elongated extension.
7. The system of claim 1 wherein the capsule is formed of flexible
material for collapsing within the internal lumen.
8. The system of claim 1 wherein the capsule is formed of a rigid
material.
9. The system of claim 1 wherein the capsule includes a distal end
and wherein the distal end of the capsule is configured to release
the bronchial obstruction device.
10. The system of claim 9 wherein the distal end of the capsule has
a rounded shape.
11. The system of claim 1 wherein the conduit is one of a
bronchoscope and a catheter.
12. A system for deploying a bronchial obstruction device in an air
passageway communicating with a lung portion to be at least
temporarily collapsed by the bronchial obstruction device, the
system comprising: a lumen means for being passed down a trachea,
into a bronchus communicating with the trachea and into the air
passageway communicating with the lung portion; and deployment
means for housing the bronchial obstruction device and dimensioned
for advancement down the lumen means into the air passageway, the
deployment means having a distal end for releasing the bronchial
obstruction device within the air passageway.
13. The system of claim 12 wherein the deployment means sealingly
houses the bronchial obstruction device.
14. The system of claim 12 wherein the distal end of the deployment
means includes a break-away portion for releasing the bronchial
obstruction device.
15. The system of claim 12 further including pushing means for
pushing the bronchial obstruction device from the deployment
means.
16. The system of claim 12 wherein the deployment means includes an
elongated extension dimensioned for receiving the pushing
means.
17. The system of claim 16 further including a break-away wall
between the elongated extension and the deployment means.
18. The system of claim 12 wherein the deployment means is formed
of flexible material for collapsing within the internal lumen.
19. The system of claim 12 wherein the deployment means is formed
of a rigid material.
20. The system of claim 12 wherein the distal end of the deployment
means has a rounded shape.
21. The system of claim 12 wherein the lumen means is one of a
bronchoscope and a catheter.
22. A method of deploying a bronchial obstruction device in an air
passageway communicating with a lung portion to be at least
temporarily collapsed, the method including the steps of: placing
the bronchial obstruction device in a housing; guiding a conduit
having an internal lumen down a trachea, into a bronchus
communicating with the trachea and into the air passageway
communicating with the lung portion; advancing the housing down the
internal lumen of the conduit into the air passageway; and
releasing the bronchial obstruction device from the housing to
deploy the bronchial obstruction device in the air passageway.
23. The method of claim 22 wherein the placing step includes the
step of sealing the bronchial obstruction device in the
housing.
24. The method of claim 22 wherein the releasing step includes the
step of breaking-away a portion of the housing.
25. The method of claim 22 wherein the releasing step includes the
step of pushing the bronchial obstruction device from the housing.
Description
BACKGROUND OF THE INVENTION
[0001] The present invention is generally directed to a treatment
of Chronic Obstructive Pulmonary Disease (COPD). The present
invention is more particularly directed to bronchial obstruction
device deployment systems and methods.
[0002] Chronic Obstructive Pulmonary Disease (COPD) has become a
major cause of morbidity and mortality in the United States over
the last three decades. COPD is characterized by the presence of
airflow obstruction due to chronic bronchitis or emphysema. The
airflow obstruction in COPD is due largely to structural
abnormalities in the smaller airways. Important causes are
inflammation, fibrosis, goblet cell metaplasia , and smooth muscle
hypertrophy in terminal bronchioles.
[0003] The incidence, prevalence, and health-related costs of COPD
are on the rise. Mortality due to COPD is also on the rise. In 1991
COPD was the fourth leading cause of death in the United States and
had increased 33% since 1979.
[0004] COPD affects the patient's whole life. It has three main
symptoms: cough; breathlessness; and wheeze. At first,
breathlessness may be noticed when running for a bus, digging in
the garden, or walking up hill. Later, it may be noticed when
simply walking in the kitchen. Over time, it may occur with less
and less effort until it is present all of the time.
[0005] COPD is a progressive disease and currently has no cure.
Current treatments for COPD include the prevention of further
respiratory damage, pharmacotherapy, and surgery. Each is discussed
below.
[0006] The prevention of further respiratory damage entails the
adoption of a healthy lifestyle. Smoking cessation is believed to
be the single most important therapeutic intervention. However,
regular exercise and weight control are also important. Patients
whose symptoms restrict their daily activities or who otherwise
have an impaired quality of life may require a pulmonary
rehabilitation program including ventilatory muscle training and
breathing retraining. Long-term oxygen therapy may also become
necessary.
[0007] Pharmacotherapy may include bronchodilator therapy to open
up the airways as much as possible or inhaled .beta.-agonists. For
those patients who respond poorly to the foregoing or who have
persistent symptoms, Ipratropium bromide may be indicated. Further,
courses of steroids, such as corticosteroids, may be required.
Lastly, antibiotics may be required to prevent infections and
influenza and pheumococcal vaccines may be routinely administered.
Unfortunately, there is no evidence that early, regular use of
pharmacotherapy will alter the progression of COPD.
[0008] About 40 years ago, it was first postulated that the
tethering force that tends to keep the intrathoracic airways open
was lost in emphysema and that by surgically removing the most
affected parts of the lungs, the force could be partially restored.
Although the surgery was deemed promising, the procedure was
abandoned.
[0009] The lung volume reduction surgery (LVRS) was later revived.
In the early 1990's, hundreds of patients underwent the procedure.
However, the procedure has fallen out of favor due to the fact that
Medicare stopping reimbursing for LVRS. Unfortunately, data is
relatively scarce and many factors conspire to make what data
exists difficult to interpret. The procedure is currently under
review in a controlled clinical trial. What data does exist tends
to indicate that patients benefited from the procedure in terms of
an increase in forced expiratory volume, a decrease in total lung
capacity, and a significant improvement in lung function, dyspnea,
and quality of life. However, the surgery is not without potential
complications. Lung tissue is very thin and fragile. Hence, it is
difficult to suture after sectioning. This gives rise to potential
infection and air leaks. In fact, nearly thirty percent (30%) of
such surgeries result in air leaks.
[0010] Improvements in pulmonary function after LVRS have been
attributed to at least four possible mechanisms. These include
enhanced elastic recoil, correction of ventilation/perfusion
mismatch, improved efficiency of respiratory muscaulature, and
improved right ventricular filling.
[0011] Lastly, lung transplantation is also an option. Today, COPD
is the most common diagnosis for which lung transplantation is
considered. Unfortunately, this consideration is given for only
those with advanced COPD. Given the limited availability of donor
organs, lung transplant is far from being available to all
patients.
[0012] In view of the need in the art for new and improved
therapies for COPD which provide more permanent results than
pharmacotherapy while being less invasive and traumatic than LVRS,
at least two new therapies have recently been proposed. Both of
these new therapies provide lung size reduction by permanently or
temporarily collapsing at least a portion of a lung.
[0013] In accordance with a first one of these therapies, and as
described in U.S. Pat. No. 6,258,100 assigned to the assignee of
the present invention and incorporated herein by reference, a lung
may be collapsed by obstructing an air passageway communicating
with the lung portion to be collapsed. The air passageway may be
obstructed by placing a bronchial obstruction device in the air
passageway. The bronchial obstruction device may be a plug-like
device which precludes air flow in both directions or a one-way
valve which permits air to be exhaled from the lung portion to be
collapsed while precluding air from being inhaled into the lung
portion. Once the air passageway is sealed, the residual air within
the lung will be absorbed over time to cause the lung portion to
collapse.
[0014] As further described in U.S. Pat. No. 6,258,100, the lung
portion may be collapsed by inserting a conduit into the air
passageway communicating with the lung portion to be collapsed. An
obstruction device, such as a one-way valve is then advanced down
the conduit into the air passageway. The obstruction device is then
deployed in the air passageway for sealing the air passageway and
causing the lung portion to be collapsed.
[0015] The second therapy is fully described in copending U.S.
application Ser. No. 09/534,244, filed Mar. 23, 2000, for LUNG
CONSTRICTION APPARATUS AND METHOD and, is also assigned to the
assignee of the present invention. As described therein, a lung
constriction device including a sleeve of elastic material is
configured to cover at least a portion of a lung. The sleeve has a
pair of opened ends to permit the lung portion to be drawn into the
sleeve. Once drawn therein, the lung portion is constricted by the
sleeve to reduce the size of the lung portion.
[0016] Both therapies hold great promise for treating COPD. Neither
therapy requires sectioning and suturing of lung tissue.
[0017] While either therapy alone would be effective in providing
lung size reduction and treatment of COPD, it has recently been
proposed that the therapies may be combined for more effective
treatment. More specifically, it has been proposed that the
therapies could be administered in series, with the first mentioned
therapy first applied acutely for evaluation of the effectiveness
of lung size reduction in a patient and which lung portions should
be reduced in size to obtain the best results. The first therapy is
ideal for this as it is noninvasive and could be administered in a
physician's office. Once the effectiveness of lung size reduction
is confirmed and the identity of the lung portions to be collapsed
is determined, the more invasive second mentioned therapy may be
administered.
[0018] In order to employ the first mentioned therapy described in
U.S. Pat. No. 6,258,100, it is necessary to deploy the bronchial
obstruction device within an air passageway. The deployment must be
reliable in that it must be done in a well controlled manner to
assure placement in the proper location. It must also be done in a
sterile manner. Patients suffering from COPD generally have
compromised health. Sterile deployment may therefore prevent a
catastrophic infection from occurring in those patients who are in
a weakened state. The present invention addresses these issues by
providing bronchial obstruction device deployment systems and
method which provide more reliable device placement and sterile
deployment conditions.
SUMMARY OF THE INVENTION
[0019] The present invention provides a system for deploying a
bronchial obstruction device in an air passageway communicating
with a lung portion to be at least temporarily collapsed by the
bronchial obstruction device. The system includes a conduit having
an internal lumen and configured to be passed down a trachea, into
a bronchus communicating with the trachea and into the air
passageway communicating with the lung portion, and a capsule
dimensioned to house the bronchial obstruction device and to be
advanced down the internal lumen into the air passageway. The
capsule is configured to release the bronchial obstruction device
for deployment in the air passageway.
[0020] Preferably, the capsule sealingly houses the bronchial
obstruction device. The capsule may further include a break-away
end portion to release the bronchial obstruction device.
[0021] The system may further include a pusher that pushes the
bronchial obstruction device from the capsule. The capsule may
further include an elongated extension communicating with the
capsule and dimensioned for receiving the pusher. The elongated
extension may be separated from the capsule by a break-away
wall.
[0022] The capsule may be formed of flexible material for
collapsing within the internal lumen or maybe formed of a rigid
material. The capsule includes a distal end which may be configured
to release the bronchial obstruction device. The distal end of the
capsule may further have a rounded shape.
[0023] The invention still further provides a system for deploying
a bronchial obstruction device in an air passageway communicating
with a lung portion to be at least temporarily collapsed by the
bronchial obstruction device. The system includes lumen means for
being passed down a trachea, into a bronchus communicating with the
trachea and into the air passageway communicating with the lung
portion, and deployment means for housing the bronchial obstruction
device and dimensioned for advancement down the lumen means into
the air passageway, the deployment means having a distal end for
releasing the bronchial obstruction device within the air
passageway.
[0024] The invention still further provides a method of deploying a
bronchial obstruction device in an air passageway communicating
with a lung portion to be at least temporarily collapsed. The
method includes the steps of placing the bronchial obstruction
device in a housing, guiding a conduit having an internal lumen
down a trachea, into a bronchus communicating with the trachea and
into the air passageway communicating with the lung portion,
advancing the housing down the internal lumen of the conduit into
the air passageway, and releasing the bronchial obstruction device
from the housing to deploy the bronchial obstruction device in the
air passageway.
BRIEF DESCRIPTION OF THE DRAWINGS
[0025] The features of the present invention which are believed to
be novel are set forth with particularity in the appended claims.
The invention, together with further objects and advantages
thereof, may best be understood by making reference to the
following description taken in conjunction with the accompanying
drawings, in the several figures of which like referenced numerals
identify identical elements, and wherein:
[0026] FIG. 1 is a simplified sectional view of a thorax
illustrating a healthy respiratory system;
[0027] FIG. 2 is a sectional view similar to FIG. 1 but
illustrating a respiratory system suffering from COPD and the
execution of a first step in treating the COPD condition in
accordance with the present invention;
[0028] FIG. 3 is a perspective view, illustrating a housing for the
bronchial obstruction device and a conduit embodying the present
invention;
[0029] FIG. 4 is a partial cross-sectional view of the housing
exiting the distal end of the conduit;
[0030] FIG. 5 is a side view illustrating a pusher just prior to
engaging the bronchial obstruction device;
[0031] FIG. 6 is another side view illustrating the device being
released from the housing by the pusher;
[0032] FIG. 7 is another side view of the device, the housing, and
the pusher immediately after the device is released from the
housing;
[0033] FIG. 8 is a side view illustrating an intermediate step in
deploying a bronchial obstruction device in accordance with an
embodiment of the present invention;
[0034] FIG. 9 is another side view illustrating a further step in
the deployment of the device; and
[0035] FIG. 10 is a side view illustrating the device after
deployment.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0036] Referring now to FIG. 1, it is a sectional view of a healthy
respiratory system. The respiratory system 20 resides within the
thorax 22 which occupies a space defined by the chest wall 24 and
the diaphragm 26.
[0037] The respiratory system 20 includes the trachea 28, the left
mainstem bronchus 30, the right mainstem bronchus 32, the bronchial
branches 34, 36, 38, 40, and 42 and sub-branches 44, 46, 48, and
50. The respiratory system 20 further includes left lung lobes 52
and 54 and right lung lobes 56, 58, and 60. Each bronchial branch
and sub-branch communicates with a respective different portion of
a lung lobe, either the entire lung lobe or a portion thereof. As
used herein, the term "air passageway" is meant to denote either a
bronchial branch or sub-branch which communicates with a
corresponding individual lung lobe or lung lobe portion to provide
inhaled air thereto or conduct exhaled air therefrom.
[0038] Characteristic of a healthy respiratory system is the arched
or inwardly arcuate diaphragm 26. As the individual inhales, the
diaphragm 26 straightens to increase the volume of the thorax 22.
This causes a negative pressure within the thorax. The negative
pressure within the thorax in turn causes the lung lobes to fill
with air. When the individual exhales, the diaphragm returns to its
original arched condition to decrease the volume of the thorax. The
decreased volume of the thorax causes a positive pressure within
the thorax which in turn causes exhalation of the lung lobes.
[0039] In contrast to the healthy respiratory system of FIG. 1,
FIG. 2 illustrates a respiratory system suffering from COPD. Here
it may be seen that the lung lobes 52, 54, 56, 58, and 60 are
enlarged and that the diaphragm 26 is not arched but substantially
straight. Hence, this individual is incapable of breathing normally
by moving the diaphragm 28. Instead, in order to create the
negative pressure in the thorax 22 required for breathing, this
individual must move the chest wall outwardly to increase the
volume of the thorax. This results in inefficient breathing causing
these individuals to breathe rapidly with shallow breaths. It has
been found that the apex portion 62 and 66 of the upper lung lobes
52 and 56, respectively, are most affected by COPD.
[0040] In accordance with the present invention, COPD treatment or
evaluation is initiated by feeding a conduit 70 down the trachea
28, into a mainstream bronchus such as the right mainstem bronchus
32, and into an air passageway such as the bronchial branch 42 or
the bronchial sub-branch 50. The conduit 70 may be a catheter or a
bronchoscope as are well known in the art. A bronchial obstruction
device, contained within a housing, is then advanced down an
internal lumen 71 of the conduit 70 and then released from the
housing in the air passageway. Once deployed, the obstruction
device precludes inhaled air from entering the lung portion to be
collapsed. It is preferable that the obstruction device take the
form of a one-way valve. In addition to precluding inhaled air from
entering the lung portion, the device further allows air within the
lung portion to be exhaled. This results in more rapid collapse of
the lung portion. However, obstruction devices which preclude both
inhaled and exhaled air flow may be deployed by the system and
method of the invention.
[0041] FIGS. 3 and 4 show a bronchial obstruction device housing
100 and a conduit 120 embodying the present invention. The housing
100 forms a sealed capsule structure for housing a bronchial
obstruction device 130 to be deployed within an air passageway. The
housing 100 has a rounded distal end 102. The rounded configuration
of the distal end 102 assists in the guiding of the housing to a
desired location within the air passageway. The housing 100, as
best seen in FIG. 4 is formed of a flexible, biocompatible material
for collapsing within the internal lumen 122 of the conduit 120 as
it is advanced through the conduit.
[0042] The housing distal end 102 further includes a score or notch
104 to enable the distal end 104 of the housing 100 to be
broken-away during deployment of the device 130 without breaking
the seal within the housing 100 until the time of deployment.
[0043] The housing still further includes a tubular extension 106
having an internal lumen 108. The lumen 108 communicates with the
interior of the housing 100 during deployment of the device 130 but
may be separated therefrom by a breakable wall 110. As will be seen
subsequently, the breakable wall 110 maintains the seal of the
housing while permitting a pusher to be advanced through the lumen
108 to break through the wall 110 at the time of deployment to then
engage the device 130. With the device 130 thus engaged, further
distal advancement of the pusher causes the device to break through
the distal end 102 of the housing weakened by the notch 104. Still
further advancement of the pusher then releases the device 130 from
the housing 100 for deployment of the device 130 at the desired
location within the air passageway.
[0044] Hence, the device 130 may be deployed in a controlled
manner. Further, the seal of the housing 100 is not broken until
the time of deployment, rendering the process sterile.
[0045] FIGS. 5-7 better illustrate the foregoing process. In FIG. 5
it may be seen that the pusher 140 has been advanced through the
lumen 108 of the extension 106 and has broken through the wall 110
previously separating the housing 100 from the lumen 108. In
accordance with this embodiment, the pusher includes a disc shaped
end 142 for engaging the device 130. Alternatively, the pusher 140
may be an appropriately shaped wire or rod. The end 142 may have a
diameter dimension slightly less than the diameter dimension of the
lumen 108. Alternatively, the extension 106 may be formed of
material flexible enough to permit the end 142 to be slightly
greater than the diameter of the lumen 108. This allows the
extension 106 to be slightly deformed as the end 142 of the pusher
140 is advanced down the extension. In either arrangement, the
pusher is slidable down the extension to break through the wall 110
and enter the housing 100.
[0046] As seen in FIG. 6, once the pusher end 142 is within the
housing 100, it then engages the device 130 upon further distal
advancement. The pusher 140 then pushes the device 130 distally to
break through the break-away distal end 102 of the housing 100.
[0047] Further advancement of the pusher 140 causes the device 130
to be released from the housing. Once released, the device 130 is
permitted to expand for deployment. Such a device is shown and
described in the aforementioned U.S. Pat. No. 6,258,100. As
previously mentioned, other forms of bronchial obstruction devices
may be deployed with the present invention. Such devices may be
one-way valves, totally blocking, expandable, or
non-expandable.
[0048] FIGS. 8-10 show a complete system 150 embodying the present
invention deploying the device 130 within an air passageway, such
as bronchial branch sub-branch 48. The system 150 generally
includes the conduit 120, the housing 100, the housing extension
106, and the pusher 140 as previously described. In FIG. 8 it may
be seen that the conduit 120 has been advanced such that its distal
end is just proximal to the bronchial sub-branch 48. The housing
100 has also been advanced through the conduit so that its distal
end 102 is within the bronchial sub-branch 48. The pusher has also
been advanced into the housing 100 for engagement with the device
130.
[0049] As seen in FIG. 9, the pusher end 142 is within the housing
100. It then engages the device 130 and upon further distal
advancement, the pusher 140 pushes the device 130 distally to break
through the break-away distal end 102 of the housing 100.
[0050] Further advancement of the pusher 140 causes the device 130
to be released from the housing in the bronchial sub-branch 48.
Once released, the device 130 is permitted to expand for deployment
in the bronchial sub-branch 48. Again, the device 130 may be of the
type shown and described in the aforementioned U.S. Pat. No.
6,258,100. The now expanded device 130 serves to obstruct the
bronchial sub-branch 48 for collapsing the lung portion
communicating with the bronchial sub-branch 48.
[0051] While particular embodiments of the present invention have
been shown and described, modifications may be made, and it is
therefore intended in the appended claims to cover all such changes
and modifications which fall within the true spirit and scope of
the invention.
* * * * *